Pelvic floor health articles and procedures

ABSTRACT

Articles and procedures for preventing or treating vaginal prolapse, urinary incontinence, and other disorders of the pelvic floor.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a Continuation of U.S. patent applicationSer. No. 11/413,285, filed Apr. 28, 2006, now allowed, which claims thebenefit of U.S. Provisional Application No. 60/676,477, filed Apr. 29,2005, the entire contents of which are incorporated herein by referencein their entirety.

TECHNICAL FIELD

The present invention relates to articles and procedures for preventingor treating vaginal prolapse, urinary incontinence, and other disordersof the pelvic floor.

BACKGROUND

In a normal female body, the levator ani muscles close the pelvic floorand support the vagina. This results in little force being applied tothe fascia and ligaments that support the vagina. Increases in abdominalpressure, failure of the muscles to keep the pelvic floor closed, anddamage to ligaments and fascia can all contribute to the development ofprolapse. Vaginal prolapse changes the position of the vagina, which canlead to discomfort, urinary incontinence, and incomplete emptying of thebladder. In severe cases, vaginal prolapse conditions can even cause thevagina to become positioned outside of the body. One specific type ofprolapse is referred to as posterior vaginal prolapse, which mayadditionally cause defecatory problems such as tenesmus and difficultyin stool evacuation. Conditions of posterior vaginal wall prolapse caninvolve descent of the rectum into the vagina, often termed a rectocele,or the presence of small intestine in a hernia sac between the rectumand vagina, called an enterocele.

Broadly, there are four types based on suspected etiology. Congenitalenteroceles are thought to occur because of failure of fusion orreopening of fused peritoneal leaves down to the perineal body.Post-hysterectomy vault prolapse can result from a lack of support fromdetachment of the uterosacral ligaments from the uterus at the time ofhysterectomy. Enterocele may occur because of failure to reapproximatethe superior aspects of the pubocervical fascia and the rectovaginalfascia at the time of a surgery. Iatrogenic prolapse may occur after asurgical procedure that changes the vaginal axis, such as certainsurgical procedures for treatment of incontinence. With regard torectoceles, the most common type of rectocele results from disruption ofconnective tissue supports of the rectovaginal fascia from its normalattachments to the uterosacral ligaments. Posterior or post-hysterectomyenteroceles may accompany rectoceles.

Several factors have been implicated as being involved in causingvaginal prolapse. It is thought that individual women have differinginherent strength of the relevant connective tissue. Further, loss ofconnective tissue strength might be associated with damage atchildbirth, deterioration with age, poor collagen repair mechanisms, andpoor nutrition. Loss of muscle strength might be associated withneuromuscular damage during childbirth, neural damage from chronicstraining, and metabolic diseases that affect muscle function. Otherfactors involved in prolapse include increased loads on the supportivesystem as seen in prolonged lifting or chronic coughing from chronicpulmonary disease, or some disturbance in the balance of the structuralsupport of the genital organs. Obesity, constipation, and a history ofhysterectomy have also been implicated as possible factors. Inparticular, the vaginal angle may be altered upon removal of the uterusin a hysterectomy, causing increased pressure at a more acute angle andthereby accelerating the prolapse.

Various techniques have been used to attempt to correct or ameliorateprolapse and prolapse symptoms, with varying degrees of success.Nonsurgical treatment of prolapse involves measures to improve thefactors associated with prolapse, including treating chronic cough,obesity, and constipation. Vaginal pessaries are the primary type ofnonsurgical treatment, but potential complications can occur such asvaginal wall ulceration. Other nonsurgical treatments may include pelvicmuscle exercises or supplementation with estrogen. These therapies mayalleviate some symptoms and temporarily provide some relief to thepatient, but any actual hernia will remain.

Surgical treatments of posterior prolapse can involve vaginal andabdominal procedures to reapproximate the attenuated tissue usingsutures or a biological or synthetic implant to provide continuingsupport of the reapproximated tissue following the procedure. Implantsthat have been used to address pelvic organ prolapse are described, forexample, in U.S. Patent Publication No. 2004/0039453, entitled “PelvicHealth Implants and Methods”, and U.S. Patent Publication No.2005/0245787, entitled “Method and Apparatus for Treating Pelvic OrganProlapse”, which patent applications are incorporated entirely herein byreference.

An example of a specific implant product designed for treatingconditions of vaginal vault prolapse is a product commercially availablefrom American Medical Systems, Inc., of Minnetonka, Minn. under thetrade designation “APOGEE”. Very generally, devices of this type aredesigned to be implanted in a manner to support vaginal tissue. Thesedevices and similar products can include various designs, such as“strips” of a single material or pieces of the same or differentmaterials connected together (e.g., mesh, tape, optionally includingsynthetic or biological tissue portions) to form an implant that can beattached at one portion to vaginal tissue, with another portion attachedat a position of the anatomy that supports the vaginal tissue.

Another pelvic floor disorder that can occur in patients is referred toas urinary incontinence or involuntary loss of urinary control, which isa problem that afflicts men, women, and children of all ages. A varietyof treatment options for incontinence are currently available. Some ofthese include external devices, behavioral therapy (such as biofeedback,electrical stimulation, or Kegel exercises), and prosthetic devices.Depending on the age, medical condition, and personal preference of apatient, surgical procedures can additionally or alternatively be usedto completely restore continence.

One type of surgical procedure found to be an especially successfultreatment option for incontinence in both men and women is a referred toas a sling procedure. Sling procedures typically entail surgicallyimplanting a biocompatible implant or “sling” to support the bladderneck or urethra in manners that are somewhat similar to those describedabove for prolapse correction techniques. Sling procedures are discussedin U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909;6,039,686; 6,042,534; 6,110,101; 6,478,727; 6,638,211; and PCTPublication Nos. WO 02/39890 and WO 02/069781, for example.

Some “pubomedial” sling procedures involve an abdominal incision andinstallation of a sling between the rectus fascia in the abdominalregion to a position below the urethra, and back again to the rectusfascia. A conventional procedure in females is to surgically place asling by entering the abdominal cavity through an incision in thepatient's pubovaginal region. In males, one exemplary conventionalmethod involves surgical placement of a sling by entering the abdominalcavity through an abdominal incision.

Other methods for treating pelvic conditions involve installation of asling below the urethra through incisions made at the inner thigh (e.g.,in the perineal skin facing the obturator and in the groin), and using atissue path extending through the obturator. These procedures can bereferred to as “transobturator” methods, which are described, forexample, in U.S. Pat. No. 6,911,003 and U.S. Patent Publication Nos.2003/0171644 and 2005/0143618, the entireties of each being incorporatedherein by reference.

While these described devices and methods of treating urinaryincontinence and vaginal prolapse can be effective, safe, andlong-lasting, there is ongoing effort toward improving these devices andmethods.

SUMMARY

One aspect of the invention relates to methods of treating urinaryincontinence by surgical implantation of a urethral sling through atissue path that traverses the obturator foramen. These “transobturator”methods generally involve two lateral incisions at the inner thigh, eachnear a patient's obturator foramen, and a third, medial incision at theperineum. An elongate sling is implanted between the medial incision andthe two lateral incisions, with opposing end portions of the slingtraversing each obturator foramen. The slings include a variety of tipsor dilator configurations at the end of the extension portions of thesling for connecting to the tips of their corresponding implantationtool or tools.

The sling can include two opposing elongate end portions that passthrough each obturator foramen and a central support portion that isplaced to support the urethra, below the urethra but not necessarily incontact with the urethra. The central support portion can be adapted forcontacting and supporting a pelvic tissue. A central support portion ofthe sling can be placed in contact with tissue below the urethra andtensioned to support pelvic tissue including the urethra, to improvecontinence.

The steps of a transobturator method can include, for example,implanting a urethral sling with end portions of the sling passingthrough the obturator, and then positioning and tensioning of a centralsupport portion of the sling to approximate or support tissue of thepelvic region such as tissue of the urethra and related pelvic tissue.Continence can be improved by approximating pelvic tissue optionally tore-align or improve the alignment or positioning of the urethra relativeto the rhabdosphincter. Desirably, the sling can be tensioned toapproximate and lift the urethra (e.g., posterior urethra) proximally,toward the bladder, and place or return the urethra to an anatomicallynormal position, improving sphincter functioning, coaptation of theurethra, and continence.

A useful urethral sling can generally be of the type currently in use asan implanted surgical device for treating urinary incontinence, as wellas similar slings developed in the future. Examples can be found in thepatent literature such as at U.S. Pat. No. 6,911,003 and U.S. PatentPublication No. 2003/0171644. Commercially available slings that couldbe useful with the articles, techniques, and methods described hereininclude the sling and implant system available from American MedicalSystems, Inc., of Minnetonka, Minn. under the trade designation“MONARC”. Urethral slings for placement at the corpus spongiosum canhave a widened central support portion for a greater area of contact andgreater amount of friction between the central support portion of thesling and the corpus spongiosum. Alternately or additionally, preferredimplants can have end portions having certain attachment and/or otherperformance characteristics.

The sling can be installed using one or more tools to manipulate theurethral sling to a desired position. Examples include curvedtwo-dimensional or three-dimensional tools shaped to allow passagebetween the lateral incision and the medial incision. End portions ofthe implant can be connected to or associated with ends of the needles,one for installing an end portion between a left-side lateral incisionand to the medial incision, through the obturator foramen. An opposingtool can assist to install the other end portion between the right-sidelateral incision and the medial incision, through the obturator foramen.Examples of these types of tools are shown, for example, in U.S. Pat.No. 6,911,003 and in U.S. Patent Publication No. 2003/0171644.Optionally, a single tool may be used to install both sides of the slingthrough the left and right obturator foramen.

Another method of treating urinary incontinence, and particularly femaleurinary stress incontinence caused by urethral hypermobility and/orintrinsic sphincter deficiency, includes using a sling systemcommercially available under the trade designation “SPARC”, which isavailable from American Medical Systems, Inc., of Minnetonka, Minn. Thissystem can be considered to utilize a suprapubic approach in whichnarrow sling carriers are passed from above the pubic bone to thevagina. A sling is attached to the carriers, such as with certaindilators and their tips or ends, and pulled into place to support theurethra. The sling may be a polypropylene mesh sling material coveredwith a plastic sheath and having locking connectors attached. Thetensioning suture of the system maintains mesh integrity during slingplacement of the sling and allows for intra and immediate post-operativetensioning while reducing sling deformation after the plastic sheath isremoved.

The invention also relates to devices, methods, and kits that are usefulfor supporting vaginal tissue in a patient who does not have a uterus,such as an implant that is designed specifically to support the vaginalcuff remaining after removal of the uterus and cervix. The supportattaches to posterior vaginal tissue remaining after removal of theuterus and cervix, and attaches also to anatomy to support the vaginaltissue, at or around the sacrum such as to uterosacral ligaments or tothe sacrum itself (i.e., to a component of the sacral anatomy). Theimplant can be attached to a component of the sacral anatomy by anychemical or mechanical attachment such as by an adhesive, a suture, abone screw or bone anchor, a staple, or any other fastener for tissue orbone. In particular, a surgeon uses an implantable device (“implant”)such as a support member, a support strip, or an implant that includes acentral support portion attached to two extension portions, to attach tothe pericervical ring or vaginal cuff remaining following removal of theuterus and cervix. The implant can be attached to uterosacral ligamentsor the sacrum to support the implant and the vaginal vault. The implantmay optionally be further supported by attachment of extension portionsof the implant to other anatomical features, e.g., a tissue path to anexternal incision, to thereby further support the vaginal vault.

An implant can include a support portion for attachment to the vaginalcuff. Specific examples of implants can include a support portiondesigned to be attached to the vaginal cuff, such as to fit around andcontact different portions of the vaginal cuff including the apex. Thesupport portion can also include one or more features or areas to attachto a component of the sacral anatomy such as the uterosacral ligamentsor the sacrum, to support the vagina, and/or treat or prevent vaginalwall prolapse. The support portion can be designed and installed toprevent possible future enterocele formation.

Optionally, the implant can include one or two or more extensionportions attached to the support portion and extending in oppositedirections from the support portion. Exemplary implants can include twoextension portions including dilators at their ends and extending inopposite directions from a central support portion. The extensionportions can be sized and shaped to extend from the central supportportion, to be attached to an anatomical position that provides supportfor the central support portion attached to the vaginal cuff. Forexample, extension portions can be led through tissue paths from theinterior pelvic area to external incisions, with the extension portionsbecoming ingrown in a manner to support the central support portion ofthe implant attached to the vaginal cuff.

Extension portions of an implant can be attached anatomically to supportthe support portion of an implant attached to the vaginal cuff. Anexemplary mode of placement of extension portions of an implant can bebilateral passage of the extension portions through tissue paths leadingto an external incision, such as an external incision at a perirectalregion as discussed in copending U.S. Patent Publication No.2005/0245787. This exemplary method includes steps of establishing afirst pathway between the external perirectal region of the patient andthe region of the ischial spine space in tissue generally on one side ofthe vaginal cuff, and establishing a second corresponding pathway intissue on the contralateral side of the vaginal cuff. Exemplary implantsas described, including a central support portion and two extensionportions, can be attached to the vaginal cuff in such a way as to allowrepositioning of the vaginal cuff to an anatomically appropriatelocation. The extension portions of the implant can then be introducedthrough the respective bilateral tissue pathways. The extension portionscan be adjusted so that the implant and central support portion arelocated in a therapeutic relationship to the vaginal cuff beingsupported.

One method of supporting vaginal tissue includes providing a surgicalimplant comprising a support portion, attaching the support portion tovaginal or cervical tissue remaining upon removal of a uterus, cervix,or both, and attaching the support portion to a component of sacralanatomy. Another method is a transvaginal method of supporting vaginaltissue includes providing a surgical implant, transvaginally attachingthe surgical implant to vaginal or cervical tissue remaining afterremoval of a uterus, cervix, or both, and transvaginally attaching thesupport portion to a component of sacral anatomy.

In one aspect of the invention, a system for treating pelvic disordersin a patient is provided, the system comprising an implant comprising asupport portion and at least one elongated portion extending from thesupport portion, wherein each elongated portion comprises a dilator at adistal end that is spaced from the support portion. The system furtherincludes an implantation tool comprising an elongated portion and an endportion that is engageable with the dilator, wherein at least one of thedilators comprises a first channel having an engagement feature forpositive engagement with the end portion of the implantation tool. Thedilator may include a spring-loaded ball extendable into first thechannel for positive engagement with the end portion of the implantationtool or may further include a second channel intersecting the firstchannel, wherein the apparatus further comprises a pin that is slideablewithin the second channel and within an aperture in the end portion ofthe implantation tool.

In another aspect of the invention, an apparatus is provided fortreating pelvic disorders in a patient, the apparatus comprising asupport portion and at least one elongated portion extending from thesupport portion, wherein each elongated portion comprises a dilator at adistal end that is spaced from the support portion, and wherein thedilator comprises a hinged end portion. In yet another aspect of theinvention, a tool is provided for treating pelvic disorders in apatient, the tool comprising a handle and a generally rigid body portionextending from the handle at a proximal end and having a distal endspaced from the handle, wherein the body portion comprises a tip portionthat is more flexible than the body portion.

In another aspect of the invention, an implant for treating pelvicdisorders in a patient is provided, the implant comprising a supportportion comprising a knit mesh having a first density, at least oneelongated portion spaced from the support portion comprising a knithaving a second density that is less than the first density and at leastone connector portion attached to the at least one support portion andto the elongated portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a schematic front view of a needle delivery system includingatraumatic needle tips positioned generally at the vaginal apex;

FIGS. 2-4 are schematic front views of a portion of three differentexemplary surgical slings in accordance with the invention, each ofwhich illustrates a different attachment between a support portion andat least one extension portion;

FIG. 5 is a schematic front view of a tool for use in surgicalprocedures, such as vaginal vault suspensions;

FIGS. 6 a-6 c are top views of three exemplary embodiments of dilatorsthat can be used with a modular graft kit;

FIG. 7 is a cross-sectional front view of a dilator portion of asurgical implant;

FIG. 8 is a front cross-sectional view of a needle end engaged with thedilator of FIG. 7, with a spring-loaded ball retaining the needle tip inposition relative to the dilator;

FIG. 9 is another cross-sectional front view of a dilator portion of asurgical implant;

FIG. 10 is a front cross-sectional view of a needle end engaged with thedilator of FIG. 9, with a sliding pin retaining the needle tip inposition relative to the dilator;

FIG. 11 is a front cross-sectional view of a needle tip including adilator-retaining feature;

FIG. 12 is a front cross-sectional view of the needle tip of FIG. 11,along with a dilator portion of a surgical implant positioned therein;

FIG. 13 is a front view of an exemplary dilator or end portion of asurgical implant, in accordance with the invention;

FIG. 14 is a front view of another exemplary dilator or end portion of asurgical implant, in accordance with the invention;

FIG. 15 is a front view of another exemplary dilator or end portion of asurgical implant, in accordance with the invention;

FIG. 16 is a front view of the dilator tip of FIG. 15, with a needle endengaged with the dilator; and

FIG. 17 is a front view of another exemplary dilator of the invention,with a needle end engaged therewith.

DETAILED DESCRIPTION

The invention relates to devices, methods, and kits, useful forpreventing or treating vaginal prolapse, urinary incontinence, and otherdisorders of the pelvic floor, with the use of implants. The implantscan have a wide variety of configurations and connections to implanttools that are designed to be used for different applications.

Exemplary implants can include a central support portion and multipleextension portions, the central support portion being useful to attachto the pelvic tissue to be supported and a component of the sacralanatomy. The central support portion contacts and supports pelvic tissue(e.g., urethral tissue, vaginal tissue, bladder tissue). The centralsupport portion can be sized and shaped to attach to the vaginal cuff atmultiple locations such as at a posterior location (e.g., rectovaginalfascia) and an anterior location (e.g., pubovaginal fascia). The centralsupport portion can also be adapted (e.g., sized and shaped) to attachto a component of sacral anatomy such as the uterosacral ligaments orsacrun. As an example, a posterior lobe of a central support portion caninclude one or more lobe extensions that are of a size and shape to beattached to the sacrum or to one or more uterosacral ligaments.

Extension portions connected to and extending from a central supportportion can be useful to attach to other anatomical features to providesupport for the central support portion and the tissue to be supported.Extension portions can extend from the central support portion aselongate “arms” or extensions that are attached to other anatomy, suchas by extending through a tissue path to an external incision. See,e.g., U.S. Patent Publication No. 2005/0080317, the entirety of which isincorporated herein by reference. The implants can have a number ofextension portions (e.g., between 2 and 6 extension portions), dependingon where the implant will be used in the body and for what type ofprocedure the implant will be used. The extension portions can extendthrough a tissue path to an exterior incision.

The total shape of exemplary implants (e.g., including a central supportportion and extension portions) can accommodate surgical placement ofthe implant to attach to anatomy. For an implant that includes a centralsupport portion and two extension portions, the extension portions canbe connected at opposing sides of the central support portion and canextend longitudinally in opposite directions away from the centralsupport portion. For implants that include more than two extensionportions extending from a central support portion, the extensionportions will be oriented around the perimeter of the central supportportion in locations that correspond with anatomical locations in thebody where the extensions will be attached or otherwise located.

Materials useful for an implant (e.g., support portion, extensionportion, central support portion, etc.) can be any of a variety ofsynthetic or biologic materials. Exemplary extension and supportportions can be prepared from any combination of synthetic and biologicor natural materials. For example, an extension portion or a supportportion may be made of a synthetic mesh (e.g., an entire implant canconsist of a support portion alone, or a central support portion andextension portions may be made entirely of a one-piece mesh). In otherembodiments, exemplary extension portions can be of synthetic mesh and acentral support portion can be of a synthetic or biologic tissuematerial. Components of a multi-piece or multi-material implant may bepre-attached or pre-assembled. For example, the portions of an implantcan be attached during manufacture, so a surgeon is not required tospend significant time cutting, connecting, or otherwise assembling thepieces of an implant prior to a surgical installation procedure.

A synthetic implant material can be any synthetic material that isuseful in an implantable surgical device, such as a biocompatiblepolymeric material or a biocompatible non-polymeric synthetic material.Examples of useful polymeric materials that may be useful in a polymericmesh include thermoplastic polymeric materials such as polyolefins(e.g., polypropylenes), polyurethanes, acetel materials, Teflon®materials, and the like; thermoset materials such as silicones; andmaterials that are otherwise curable, e.g., that can be cured byultraviolet radiation or chemical reactions, including curable materialssuch as curable urethanes, epoxies, acrylates, cyanoacrylates, and thelike. Any of these materials may be homopolymers, copolymers, or a blendor other combination of homopolymers, copolymers, or both. Othersuitable synthetic materials include metals (e.g.; silver filigree,tantalum gauze mesh, and stainless steel mesh).

A synthetic implant material may be in any form, such as a continuous,solid, or semi-continuous (e.g., perforated) film; or in the form ofcombined fibers or strands, such as a braided, knit, tied, mesh, woven,non-woven, or fabric-type of material; or combinations of these. Certainembodiments of implants include a synthetic implant portion in the formof a polymeric mesh material. The mesh material includes one or morewoven, knitted or inter-linked polymeric filaments or fibers that formmultiple fiber junctions throughout the mesh. The fiber junctions may beformed via weaving, knitting, braiding, joining, ultrasonic welding orother junction forming techniques, including combinations thereof,leaving openings or pores (“interstices”) between elements of thefibers. The size of the interstices mesh may be sufficient to allowtissue in-growth and fixation within surrounding tissue.

Many different types of synthetic film and mesh materials are known andmay be suitable for use as a portion or piece of an implant such as anextension portion or a central support portion. These materials may beprepared from biocompatible materials that may be bioabsorbable ornon-bioabsorbable, e.g., in the form of mesh materials. Suitablematerials include cotton, linen, silk, polyamides (polyhexamethyleneadipamide (nylon 66), polyhexamethylene sebacamide (nylon 610),polycapramide (nylon 6), polydodecanamide (nylon 12), andpolyhexamethylene isophthalamide (nylon 61), and copolymers and blendsthereof), polyesters (e.g., polyethylene terephthalate, polybutylterephthalate, copolymers and blends thereof), fluoropolymers (e.g.,polytetrafluoroethylene and polyvinylidene fluoride), polyolefins (e.g.,polypropylene, including isotactic and syndiotactic polypropylene andblends thereof, as well as blends composed predominantly of isotactic orsyndiotactic polypropylene blended with heterotactic polypropylene, andpolyethylene), silicone, polygalactin, Silastic, polycaprolactone,polyglycolic acid, poly-L-lactic acid, poly-D-L-lactic acid andpolyphosphate esters.

Commercial examples of polymeric materials for use in an implant includeMARLEX (polypropylene) available from Bard of Covington, R.I.; PROLENE(polypropylene) and PROLENE Soft Polypropylene Mesh or Gynemesh(nonabsorbable synthetic surgical mesh), both available from Ethicon, ofNew Jersey; MERSILENE (polyethylene terephthalate) hernia mesh alsoavailable from Ethicon; GORE-TEX (expanded polytetrafluoroethylene)available from W.L. Gore and Associates, Phoenix, Ariz.; INTEPRO™polypropylene materials, and the polypropylene material used in thecommercially available SPARC® sling system, each available from AmericanMedical Systems, Inc. of Minnetonka, Minn. Commercial examples ofabsorbable materials include DEXON (polyglycolic acid) available fromDavis and Geck of Danbury, Conn., and VICRYL available from Ethicon.

Suitable non-synthetic (biologic) implant materials include allografts,homografts, heterografts, autologous tissues, cadaveric fascia,autodermal grafts, dermal collagen grafts, autofascial heterografts,whole skin grafts, porcine dermal collagen, lyophilized aortichomografts, preserved dural homografts, bovine pericardium, and fascialata.

According to certain embodiments of implants, various additionalcomponents and features can be incorporated for added utility orconvenience, such as components and features that facilitateinstallation of a device during a surgical procedure. For instance, atensioning member (e.g., suture) may be attached to an implant along aportion or entire length of an extension member for use in addingtension or in positioning an implant or a portion (e.g., extension) ofan implant. Alternately or in addition, an exemplary implant may includea removable sheath such as a plastic, transparent elongate tube, etc.,that can cover a portion or entire length of an extension portion of animplant to facilitate installation by allowing a surgeon to applytension or pressure on the sheath to indirectly apply pressure ortension to the extension portion. Additionally or alternately, extensionportions of an implant may include a connector or “dilator” tip at anend of an extension member distal from a central support member, theconnector being able to cooperate with an insertion tool (e.g., needle,tunneler, etc.) during a surgical procedure to either push or pull theconnector using the end of the insertion tool. For example, a tip may bea rigid plastic tip or “dilator” constructed to attach to an end of anelongate insertion tool by snapping or otherwise securing to the end ofthe tool. The tool can then be used to push or pull the connectorthrough a tissue passage to also bring the extension portion of theimplant through the tissue passage. Variations in these dilators andinsertion tools, including methods and devices to provide easierattachment between the components, are described herein, in accordancewith the invention.

Referring now to the Figures, wherein the components are labeled withlike numerals throughout the several Figures, and initially to FIG. 1,one preferred configuration of a needle delivery system 10 isillustrated, as positioned relative to a vaginal apex 12. Deliverysystem 10 generally includes a stylette needle 14 and a second needle16. Needle 14 includes a handle 18, a body portion 20 having a meshmaterial 22 housed therein, and a distal tip or dilator 24. Needle 16includes a handle 26, a body portion 28, and a distal tip or dilator 30.This system 10 is used to help physicians to visualize and/or insert amesh to the vaginal apex for a vault suspension in a blinded approach.Body portions 20, 28 of the needles each are designed to have anappropriate length and curvature to provide access to the vaginal apexor other area of the anatomy where such a system can be used. System 10may also be referred to as an apical suspension kit in which pre-loadedmesh 22 and needle 14 are delivered together to the surgical site (e.g.,the vaginal apex). In the surgical technique, distal tips 24, 30 arealigned with each other, such as in a self-aligning arrangement. Distaltips 24, 30 are then mated or engaged with each other at the apex, withmesh 22 pre-attached to a dilator grommet at the distal tip 24. Distaltips 24, 30 may engage with each other in a number of ways, such as withthe snap-fit type of connection illustrated in FIG. 1, or with anothertype of positive-engagement connection.

Once tips 24, 30 engage with each other, both needles 14, 16 can bepulled out, thereby pulling mesh 22 out of body portion 20 of needle 14via the dilator grommet connection at distal tip 24. In this way, aphysician does not need to feed a dilator/mesh material individuallythrough the vaginal orifice to snap onto a needle. The mesh material 22can then be attached to the vaginal cuff, for example.

FIGS. 2-4 illustrate different attachment methods and configurations forconnecting surgical sling portions to each other. First, FIG. 2illustrates a first mesh portion 34, which may be a mesh of a SPARCimplant, for example, and a second mesh portion 36, which may be asofter or looser density mesh than that of first mesh portions 34 (e.g.;a non-resorbable synthetic prosthesis material, such as is commerciallyavailable from Johnson & Johnson of New Brunswick, N.J. under the tradedesignation “Gynemesh”). Mesh 36 is shown as attached to first meshportion 34 via two extensions 38, 40, between which a bladder neck 42 ispositioned. Extensions 38, 40 meet mesh portion 34 at transition areas44, 46, respectively, which are knitted areas that provide a transitionbetween first mesh portion 34 and the relatively more open and softermesh material of second mesh portions 36. This connection may beperformed by a knitting machine, for example, and is intended to providean area with a mesh that has intermediate properties as compared to mesh34 and mesh 36.

Extensions 38, 40 may make a bioresorpable attachment between first andsecond mesh portions 34, 36 in order to have a relatively rigidconnection during the implantation process for ease of use. However,this rigid connection can disappear or degrade before tissue in-growthto minimize or avoid constraint of the bladder neck when in-growth takesplace.

FIG. 3 illustrates another first mesh portion 50, which may be a mesh ofa SPARC implant, for example, and a second mesh portion 52, which mayagain be softer density mesh than that of first mesh portion 50. Meshportion 52 is attached to mesh portion 50 via two extensions 54, 56,between which a bladder neck 58 is positioned. Extensions 54, 56 areattached to first mesh portion 50 with an attachment method that doesnot involve additional knitting, as with the system of FIG. 2, butinstead is attached with a spot weld, laser weld, bioarc sutureattachment, ultrasonic welding, or the like. Second mesh portion 52further includes at least one anatomical landmark or sizing demarcation60, such as colored sutures and/or ink markings. Demarcation(s) 60 allowthe surgeon to customize the graft to each patient's particular anatomy.

FIG. 4 illustrates another first mesh portion 64, which may be a mesh ofa SPARC implant, for example, and a second mesh portion 66, which mayagain be a softer or looser density mesh than that of first mesh portion64. Mesh portion 64 is attached to mesh portion 66 via two extensions68, 70, between which a bladder neck 72 is positioned. Extensions 68, 70are provided as loose suture attachments that can be knotted (such as atan assembly area) at one or both of their ends to the first and secondmesh portions 64, 66. These extensions 68, 70 may be made of a permanentor bioresorpable material, and are designed to avoid rigid attachment,which can thereby alleviate possible bladder neck fimnelingconstriction. That is, if a bioresporpable suture is used, it willabsorb before permanent in-growth to avoid bladder neck constriction.

With respect to the embodiments of FIGS. 2-4, a flexible neck attachmentfrom the first mesh portion (e.g., an incontinence sling) to the secondmesh portion (e.g., an anterior patch) will allow for natural dynamicsof the bladder neck and vaginal wall to act independently. If abioresorpable suture or mesh is used to allow for ease of implantation,the attachment will be temporary since the material will absorb quicklybefore the body relies on in-growth. This may prevent scar tissuebuildup, which may in turn prevent bladder neck funneling.

FIG. 5 illustrates a needle 80 for use particularly in vaginal vaultsuspensions, although it may also be useful in other applications.Needle 80 includes a relatively rigid or non-malleable shaft 82, ahandle 84, and a tip portion 86. Needle 80 provides the surgeon with theability to change the orientation of at least a portion of the needleonce it is positioned within the patient. This can be particularlyadvantageous, for example, in procedures where the surgical instrumentfirst passes through a relative straight body opening, but then the endportion of the needle needs to be bent or angled differently to access acertain portion of the anatomy. Shaft 82 has a preset shape that isdesigned to move through the fascia muscle, for example. Tip 86 isrelatively flexible or malleable as compared to shaft 82, and isprovided so that it can be bent or redirected as compared to shaft 82 tomake it easier to insert a mesh to the vaginal apex for vaultsuspension. This is accomplished through a flexible and/or malleableand/or steerable tip on the end of a needle portion having a pre-setshape (e.g., shaft 82) to snap or otherwise attach onto a dilator to getthe mesh anchored to the vaginal apex.

Tip portion 86 can be made of a single piece of relatively flexiblematerial, for example, and/or may include another configuration thatuses less flexible materials arranged in a way that allows articulationbetween adjacent portions (i.e., articulating knuckle joints) or couldinclude a steerable coil. An alternative tip portion is illustrated asconnection 88, which includes a series of snap-fit links 90 coupled toeach other in such a way to provide flexibility to the tip portion. Inany case, the tip portion of needle 80 allows for bending to anappropriate flexure radius for accessing the desired area of thepatient's anatomy.

With regard to dilators used with slings in surgical procedures of thetype described herein, and in accordance with the invention, a modularsystem is provided for use with a modular graft kit. A modular graft kitmay include several different needles to be used by a physician,depending on the approach taken or where the graft may be attached. Inorder to make it easier for the physician to match each needle to itscorresponding dilator, each dilator can be keyed or coded in such a waythat it is identifiable to be associated with a certain needle tip. Inone example, a dilator and needle that are intended to be used togethercan each have a portion that is the same color, for easy visualidentification of associated needles and dilators. In another example,which is illustrated in FIGS. 6 a-6 b, dilators are keyed differentlyfor each needle attachment to prevent using the wrong needle with aparticular dilator. This type of system can be used as a kit havingmultiple surgical implants (with dilators) and multiple tools, in whichwould not be possible for a surgeon to inadvertently attach a needle tipto a surgical implant that is supposed to be used in a different area ofthe patient. In this exemplary embodiment, FIG. 6 a illustrates aprofile of a first dilator 90, which may be used in a posterior surgicalapproach, for example; FIG. 6 b illustrates a profile of a seconddilator 94, which may be used in a transobturator surgical approach, forexample; and FIG. 6 c illustrates a profile of a third dilator 97, whichmay be used in a suprapubic surgical approach, for example, although thetools can be provided for different surgical techniques than listed. Asshown, dilator 90 includes an opening 92 having a first shape, dilator94 includes an opening 96 having a second shape, and dilator 97 includesan opening 98 having a third shape. First, second, and third shapes 92,96, and 98 are at least slightly different from each other, andpreferably will only allow attachment of a particular needle tip. Thus,if a surgeon were to perform a surgery that involves a transobturatorsurgical approach, for example, the surgeon could select the needle tobe used in the surgery, which would have a needle tip to which only acertain dilator (e.g.; second dilator 94) would be attachable. Theprofile of each of the dilators can also be different sizes.

In cases where a system allows use of multiple dilators with the sameneedle (i.e., in systems where multiple implants have the same dilatorconfiguration), it is possible that a physician can insert the wrongneedle onto the dilator. In these cases, a universal, quick releasedilator can be provided that would allow the physician to remove theneedle from a dilator if it is inserted onto the incorrect needle. Thisuniversal dilator is configured to prevent twisting of the mesh andprovide easy removal if the wrong dilator is attached to a needle. Thisconcept would also allow aid in providing inventory management since thekits can be provided with generic dilators that would fit onto anyneedle tip.

In accordance with another aspect of the invention, needle systems areprovided that include features at the needle tip that allow for easyadvancement of the needle through the patient's tissue, such as can beused with the systems designated by the trade designations “SPARC” and“MONARC”, both of which are commercially available from American MedicalSystems, Inc., of Minnetonka, Minn. These needle systems allow for amore blunt/atraumatic passage of the needle, and further have theability to engage securely with corresponding dilators. These needlesystems are particularly advantageous in areas of the body where a sharpneedle tip will be in close proximity to structures that areparticularly susceptible to being damaged, for example. For theseapplications, a needle head or tip is provided that is at least slightlylarger than the elongated portion of the needle, but that is relativelyblunt or rounded to allow for safer passage of the needle through thebody tissues. The slightly larger size of the needle head or tip canprovide a larger radius, which in turn can provide for smoother passagethrough the tissue.

One example of such a needle system is illustrated in FIGS. 7 and 8,where FIG. 7 illustrates a dilator 100 having an inner channel 102 thatextends through at least a portion of dilator 100. Dilator 100 furtherincludes a spring 104 (shown here in a retracted position, for claritypurposes) and a ball 106 that allow for a spring-loaded connection withthe needle 108, as shown in FIG. 8. In particular, a ball end 110 ofneedle 108 is sized so that it can move ball 106 to compress spring 104when it is being pressed into the channel 102, until ball 110 movesbeyond the spring 104 and ball 106. Due to the force of spring 104, ball106 will then engage with needle 108 below ball 110, thereby retainingneedle 108 in this position relative to dilator 100. Thus, spring 104should be capable of providing sufficient force to maintain needle 108in its engaged configuration.

Another example of a needle system similar to that of FIGS. 7 and 8 isillustrated in FIGS. 9 and 10, where FIG. 9 illustrates a dilator 120having a first inner channel 122 that extends through at least a portionthereof, and a second inner channel 124 that intersects channel 122.Channel 124 may be essentially perpendicular to channel 122, as shown,or may instead be at an angle relative to channel 122. Dilator 120further includes a sliding pin 126 that allow for a positive engagementwith a needle 128 having an end 130, as shown in FIG. 10. In particular,needle 128 can be pressed into channel 122 of dilator 120 until its end130 is positioned so that a hole through it (not visible in this figure)is aligned with channel 124. Sliding pin 126 can then be slid throughchannel 124 and the hole through end 130 of needle 128, therebyproviding a positive engagement between sliding pin 126 and needle 130.Channel 124 can extend all or part of the way through dilator 120, butshould be long enough so that the sliding pin 126 can sufficientlyengage with the needle 130. This system may include multiple slidingpins, if desired, or may include multiple needle retentionconfigurations, such as a system that includes both a spring loadedball, as in FIGS. 7 and 8, in combination with a sliding pin mechanism,as in FIGS. 9 and 10, for example.

Another example of a needle system engagement configuration isillustrated in FIGS. 11 and 12. FIG. 11 illustrates a needle tip 140with an inner channel 142 having an extension 144, which functions as adilator-retaining feature. FIG. 12 illustrates a dilator portion 146 ofa surgical implant positioned within inner channel 142. Dilator portion146 includes at least one extension 148 that engages with the extensionof inner channel 144 in a number of different ways, one of which isillustrated in FIG. 12. In particular, extension 144 includes anenlarged portion 150 that has a larger cross-section than the area 152immediately below it, and dilator 146 includes a channel 154 with atleast one extension 148. When dilator portion 146 is pushed into needletip 140, the extension(s) 148 move or flex away from the enlargedportion 150 until the enlarged portion 150 is on the opposite side ofthe extension(s) 148, thereby keeping the dilator portion 146 securelyengaged with the needle 140. Alternatively, a sliding pin arrangementmay be used with this general configuration.

FIGS. 13-17 illustrate dilator and needle tip variations that areparticularly useful in low-clearance anatomy applications, such as foraccessing the area of the vaginal vault, such as with the systemscommercially available under the trade designation “SPARC” or “MONARC”from American Medical Systems, Inc., of Minnetonka, Minn. In at leastsome of the embodiments, a needle tip can be attached to a dilator fromthe side, which is particularly beneficial in areas where the surgeonhas limited access to the area. FIG. 13 illustrates a dilator 160engaged with a needle 162, where the dilator 160 is hinged to be able tomove in the directions indicated by arrow 164, such as about one or morehinge pins 166. FIG. 14 illustrates a dilator 170 engaged with a needle172, where the dilator 170 includes a socket portion 176 about which aball portion 174 can rotate, although these portions may beinterchanged. Dilator 170 can thus move in the directions indicated byarrow 178 through a ball-in-socket type of connection. These hingeddilators can allow easier attachment of the dilator to the needle, andcan also more easily follow a relatively tortuous needle path,particularly during withdrawal of the needle. In addition, these hingedor moveable dilators can be provided with a locking function to allowthe dilator to be fixed in a certain position, then released to bemoveable, such as to do a perpendicular connection between a dilator andneedle tip.

FIG. 15 illustrates a dilator 180 having a channel 182 extending atleast partially through its length. In FIG. 16, a needle 184 is engagedwithin the channel 182. Dilator 180 can be snapped onto the needle 184from the side instead of the top, then further connected with an axialmovement of the needle relative to the dilator, which allows for analternative attachment path that is advantageous in tighter spaces.

FIG. 17 illustrates another dilator 190 engaged with a needle 192.Needle 194 engages with extensions 196 of dilator 190 to retain theneedle 194 relative to dilator 190 in a similar manner to the engagementconfiguration described above relative to FIG. 13. Dilator 190 furtherincludes a hole 198 for retaining a mesh material that can position themesh beside the needle rather than above the needle, which allows thesystem to be at least slightly shorter or more compact.

In another aspect of the invention, a tool is provided that a physiciancan use to determine the size of mesh and/or the shape of a mesh neededfor a patient's anatomy. This tool can be used in combination with acape or support portion (e.g., with a support portion of a SPARC device)that has demarcations on the mesh that identifies a shape and size thata physician can trim. The tool can be a pessary-like and/or Badenspeculum tool that identifies the size and shape of a mesh needed torepair a cystocele defect, for example. In this way, the physician wouldnot need to guess at what type of shape or size the graft would need tobe for a cystocele repair, for example. In other words, the shape andsize of a patient is determined before the mesh is trimmed.

Surgical installation using methods and devices described herein caninvolve methods that are laproscopic, abdominal (involving an abdominalincision) or transvaginal. In exemplary transvaginal methods, followingattachment of a central support portion of an implant to the vaginalcuff, extension portions of an implant can be secured to support thecentral support portion and the vaginal cuff. This can be done, e.g., byestablishing tissue pathways to exterior incisions and leading theextension portions through the tissue pathways.

Exemplary methods of providing tissue pathways from the vaginal regionto external incisions, for installing an implant to support vaginaltissue, are described in US Patent Publication No. 2005/0245787,entitled “Method and Apparatus for Treating Pelvic Organ Prolapse”.Other methods will also be useful. As described in the referenced patentapplication, two tissue pathways are established between the externalperirectal region and the region of the ischial spine. Tools useful forthis procedure can be straight or curved needles, optionally including atip with an adapter that cooperates with a tip or dilator at the end ofextension portions of the implant, to allow the dilator of the endportion to be attached to the tip of the needle to lead the dilator andextension portion to a desired location, e.g., through a tissue path toan external incision. The dilator variations described herein may beused alone or in combination with each other for a single needle system,as desired.

A useful needle can be generally curved or arcuate. A variety of needledesigns may be used including, without limitation, straight, bent,curved, arc-shaped, Stamey, Raz and other configurations. Another toolthat may be useful is a tunneler (e.g., the IVS Tunneler deviceavailable commercially from Tyco), which can also be inserted from anexternal incision to attach to an end of an extension portion to allowthe extension portion to be led from the pelvic region to an externallocation.

The present invention has now been described with reference to severalembodiments thereof. The entire disclosure of any patent or patentapplication identified herein is hereby incorporated by reference. Theforegoing detailed description and examples have been given for clarityof understanding only. No unnecessary limitations are to be understoodtherefrom. It will be apparent to those skilled in the art that manychanges can be made in the embodiments described without departing fromthe scope of the invention. Thus, the scope of the present inventionshould not be limited to the structures described herein, but only bythe structures described by the language of the claims and theequivalents of those structures.

1. A system for treating pelvic disorders in a patient, the systemcomprising: an implant comprising a support portion and at least oneelongated portion extending from the support portion, wherein eachelongated portion comprises a dilator at a distal end that is spacedfrom the support portion; and an implantation tool comprising anelongated portion and an end portion that is engageable with thedilator; wherein at least one of the dilators comprises a first channelhaving an engagement feature for positive engagement with the endportion of the implantation tool and a spring-loaded ball extendableinto the first channel for positive engagement with the end portion ofthe implantation tool.
 2. (canceled)
 3. A system for treating pelvicdisorders in a patient, the system comprising: an implant comprising asupport portion and at least one elongated portion extending from thesupport portion, wherein each elongated portion comprises a dilator at adistal end that is spaced from the support portion; and an implantationtool comprising an elongated portion and an end portion that isengageable with the dilator and an aperture that extends through the endportion; wherein at least one of the dilators comprises a first channelhaving an engagement feature for positive engagement with the endportion of the implantation tool and a second channel that has two openends and that intersects the first channel, and wherein the systemfurther comprises a pin that is insertable into one of the two open endsof the second channel and slideable within the second channel and withinthe aperture in the end portion of the implantation tool when theaperture is aligned with the second channel of the dilator.
 4. Thesystem of claim 3, wherein the pin is removable from at least one of theopen ends of the second channel.
 5. An apparatus for treating pelvicdisorders in a patient, the apparatus comprising: a support portion; andat least one elongated portion extending from the support portion,wherein each elongated portion comprises a dilator at a distal end thatis spaced from the support portion; wherein the dilator comprises ahinged end portion that comprises a first structure having alongitudinal axis and a second structure having a longitudinal axis,wherein the longitudinal axis of the first structure is pivotable abouta hinge pin between coaxial and non-coaxial positions relative to thelongitudinal axis of the second structure. 6-7. (canceled)
 8. A systemfor treating pelvic disorders in a patient, the system comprising: animplant comprising a support portion and at least one elongated portionextending from the support portion, wherein each elongated portioncomprises a dilator at a distal end that is spaced from the supportportion; and an implantation tool comprising: a handle; and a generallyrigid body portion curved to a first curvature profile, extending fromthe handle at a proximal end, and having a distal end spaced from thehandle, wherein the body portion comprises a tip portion that is moreflexible than the body portion and wherein the tip portion is curved toa second curvature profile that is different from the first curvatureprofile; wherein at least one of the dilators comprises a first channelhaving an engagement feature for positive engagement with the tipportion of the implantation tool.
 9. (canceled)
 10. The system of claim8, wherein the tip portion is maneuverable to at least a third curvatureprofile. 11-12. (canceled)
 13. The system of claim 8, wherein the tipportion is malleable.
 14. An implant for treating pelvic disorders in apatient, the implant comprising: a support portion comprising a knitmesh having a first density; at least one elongated portion spaced fromthe support portion comprising a knit having a second density that isless than the first density; and two connector portions spaced from eachother to define an open space that is sufficient to span a bladder neckof a patient, wherein each connector portion is attached at a first endto the at least one support portion and attached at a second end to theelongated portion.
 15. (canceled)
 16. The implant of claim 14, whereinthe support portion comprises at least one visual indicator. 17.(canceled)
 18. The implant of claim 14, wherein the attachment betweeneach of the connector portions and the elongated portion is a permanentattachment.
 19. The implant of claim 14, wherein the attachment betweeneach of the connector portions and the elongated portion is abioresorpable attachment.
 20. The implant of claim 14, wherein theattachment between each of the connector portions and the elongatedportion is a knot suture attachment.
 21. A system for treating pelvicdisorders in a patient, the system comprising: at least two implants,each comprising a support portion and at least one elongated portionextending from the support portion, wherein each elongated portion ofeach implant comprises a dilator having a profile at a distal end thatis different from a profile at a distal end of each of the otherimplants; and at least one implantation tool comprising an elongatedportion and an end portion that is selectively engageable with theprofile at the distal end of the dilator of only one of the implants;wherein at least one of the dilators comprises a first channel having anengagement feature for positive engagement with the end portion of theimplantation tool.
 22. The system of claim 21, wherein the implants areselected from the group of implants that can be used for a posteriorsurgical approach, a transobturator surgical approach, or a suprapubicsurgical approach.